FDA panel rebuffs AstraZeneca's early ESR1-driven camizestrant approach in breast cancer
An FDA advisory panel voted 6-3 against approving AstraZeneca's oral SERD camizestrant for HR-positive, HER2-negative metastatic breast cancer with ESR1 mutations detected before progression, citing insufficient evidence of a meaningful long-term benefit and trial-design concerns (no crossover, OS data immature). Approval now seems unlikely despite a progression-free survival improvement seen in Serena-6.